Suture capture and tensioning arrangement in a machine for the automated packaging of needles and attached sutures

ABSTRACT

A machine for the automated packaging of armed sutures or; in effect, surgical needles having sutures attached thereto and, more particularly, a suture capture and tensioning arrangement in an automated machine for the high-speed individualized packaging of single or individual surgical needles each having an attached suture into a tray and detachable cover providing a suture package utilized for the packaging of the individual or single needles and attached sutures.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a machine for the automated packagingof armed sutures or; in effect, surgical needles having sutures attachedthereto and, more particularly, pertains to a suture capture andtensioning arrangement in an automated machine for the high-speedindividualized packaging of single or individual surgical needles eachhaving an attached suture into a tray and detachable cover providing asuture package utilized for the packaging of the individual or singleneedles and attached sutures. Additionally, the automated packagingmachine incorporates operative mechanism adapted to wind the suturesinto a peripheral channel of the tray and facilitating the attachment ofthe cover to the tray which contains the single needle and attachedwound suture, and which cover concurrently constitutes aproduct-identifying label as a component of the tray. The cover beingshaped such that removal of the cover is not necessary to enable a userto gain access to the contents of the tray; in essence, the armedsuture.

The automated packaging machine also provides for a rotary turret ordial-like turntable for the high-speed loading thereof with empty trays;the sequential loading of successive forwardly indexed trays each with aneedle and attached suture; the indexed advance of the needle andsuture-filled tray to suture-winding stations of the machine duringwhich interval the portions of the suture which extends outwardly of thetray in which the needle is packed is maintained under a predeterminedcontrolled tension; the conveyance of the trays each containing theneedle and attached wound suture to a cover-applying station of themachine to provide the completed suture packages, and the furtheradvance of the suture packages for subsequent automated removal of thecompleted suture packages from the machine. The automated packagingmachine is resultingly adapted to provide for the continuous andrepetitive production of suture packages in a single high-speedproduction cycle without necessitating any manual manipulation thereof.

In order to facilitate the production of the suture packages asdescribed herein, the present invention provides for a plurality ofsequential operating stations, in which a first station includescarousel structure having stacked package trays sequentially conveyed toa rotary plate element which slices off or separates the bottommostpackage tray from a stack of trays, and includes operative robotic pivotarm structure for transferring the separated package tray to a tool nestmounted on a rotary dial for transfer to subsequent processing stations,where the package tray is provided with an armed suture, the suturewound into the package tray, a cover applied thereto to produce thefinished package, and which is then removed from the packaging machineand further transported for additional processing and/or storage.

The present invention as disclosed herein is particularly directed tothe provision of a novel arrangement and method for the automatedcapturing and tensioning of the sutures upon and subsequent to theintroduction and transfer at a needle feed workstation of singlesurgical needles and portions of attached sutures into individualpackaging trays until any remaining portions of the sutures which extendoutwardly and downwardly from the trays mounting the surgical needlesare wound into the trays in their entirety, so as to thereafter enablethe application of covers thereto in sequential production steps throughthe intermediary of the automated packaging machine.

With respect to the foregoing, the capturing and tensioning of thesuture portions extending outwardly and downwardly of the trays isimplemented through the intermediary of novel vacuum clamp structurewhich is mounted on the turntable and operatively associated with eachrespective tool nest, and further controllable vacuum guide structurefor guiding and tensioning the suture portions until these are woundinto the confines of the packaging tray.

Currently, in the medical, surgical and health-related technology, thehigh-speed and efficient packaging of either single or multiple sutureswhich are each suitably attached to surgical needles, such as by beingswaged or similarly fastened thereto, and in which such combined sets ofneedles and sutures are generally referred to as armed sutures, isimparted an increasing degree of importance in view of the rising demandof users for such combined surgical needles and attached sutures, andvarious diverse types of inexpensively manufactured suture packages forthe containment of needles and attached sutures have been developed andare presently widely employed.

In specific instances, suture packages may be covered tray-shapedcontainers designed to receive and fixedly retain therein one or moreneedles and therewith attached sutures, in which the suture packages,upon opening of the covers, must enable the uncomplicated and simplewithdrawal of a respective individual needle and its attached suture ina smooth unobstructed manner. In essence, when the needle which is to beremoved from the suture package is engaged by a surgeon or healthprofessional, for example, by being gripped through the intermediary ofa forceps and then pulled out of the suture tray, it is essential thatthe needle easily disengage from its restraint in the package while thesuture which is attached to the needle should also be readily able toslip out of the tray in the absence of any binding or snagging, and inthe instance of the tray housing a plurality of armed sutures alsowithout becoming entangled with other sutures still remaining in thesuture tray or package. Thus, pursuant to a specific needle and suturepackage construction which, for example, may comprise aninjection-molded plastic tray, the needles are generally engaged byclamping structure located in the tray so as to be "parked" or retainedin predetermined position or array in a central region of the tray. Thesutures extending from the needles to which they are attached, whilebeing maintained captured under a controlled tension are then conductedinto and deposited in a peripheral channel formed within the confines ofthe suture tray so as to extend along the peripheral length of thechannel. This positioning of the needles, and particularly that of thesutures within the peripheral channel of the tray is intended toeliminate tight bends or curves normally imposed on the sutures so as tofacilitate their easy withdrawal from the suture package.

2. Discussion of the Prior Art

Until relatively recently, the introduction of needles with attachedsutures into suture packages or molded plastic trays was beingimplemented in a substantially manual manner. In that instance, theneedles were manually placed into the tray so as to be clampinglyengaged by means of suitable needle-gripping structure, and thereafterthe attached sutures wound or positioned within the confines of thetray. Subsequently, a suitable cover was superimposed upon and fastenedto the filled tray, and the resultant armed suture package conveyed to asuitable arrangement for possible sterilizing or further over wrapping.

The foregoing essentially manual and relatively basic process forwinding the sutures into the tray, and especially the locating thereofinto the peripheral channel of the tray during manipulation of the tray,was quite time-consuming, and in conjunction with the manual applicationof the cover into the tray in a basically individual or piece-by-piecemode, represented a serious hindrance to a large volume or mass producedmanufacturing output, and adversely affected the economics in attemptingto provide such large quantities of suture packages containing eithersingle or multiple surgical needles and attached sutures.

As an improvement over the foregoing, there was then developed agenerally semi-automated winder machine for packaging surgical needlesand attached sutures in a tray-like suture package, and wherein at leastsome of the previously manually implemented packaging steps were to someextent automated in order to be able to increase the output of needleand suture-containing packages while simultaneously reducing the numberof manual procedures in effectuating the packaging of those particularitems.

To that effect, the semi-automated winder machine, althoughnecessitating the manual orientation of the trays for implementing thefilling thereof with needles and attached sutures, included a windingstation which to a considerable degree automated the winding process forthe sutures so as to place the latter into a peripheral channelextending about the circumference of the tray. Also provided was afurther therewith operatively associated device which enabled covers tobe manually placed on the needle and suture-filled trays to be fastenedthereto by means of a pressing die forming latchingly engaginginterconnections between each of the covers and the trays, whileconcurrently producing from a portion of the cover a product-identifyinglabel which remains permanently attached to the tray upon subsequentdetachment of the cover. Although providing a considerable advance overthe state-of-the-art in the packaging of needles and sutures, thesemi-automated winder machine nevertheless necessitated theimplementation of a considerable number of manual and labor-intensivehandling steps in effectuating the filling of the trays with surgicalneedles and attached sutures, attaching the cover and, generally,producing complete suture packages.

As a further technological advance over the foregoing semi-automatedneedle and suture package-forming concept, there was then developed asubstantially fully automated packaging machine which is adapted, in ahighly efficient and extremely rapid mode, to continually fillsuccessive trays of the type described hereinabove with pluralities ofsurgical needles and attached sutures, and subsequently causing thesutures to be wound into the confines of the tray, such as into aperipheral channel extending about the tray. Thereafter, the packagingmachine was designed to implement the automated positioning andfastening of covers to the needle and suture-filled trays to producecompleted suture packages of the type described hereinabove, which werethen adapted to be transported to a suitable locale for selectivefurther processing, such as sterilizing, and/or over wrapping, as isrequired by this technology.

In particular, the automated packaging machine was designed to providethe packages with each housing a plurality of needles and attachedsutures. For example, the packaging machine for accomplishing theforegoing, which is commonly assigned to the assignee of the presentapplication, is described in U.S. Pat. Nos. 5,487,212; 5,473,854;5,469,689; 5,473,810; 5,511,670; 5,452,636; 5,438,746; 5,500,991;5,477,609; 5,485,668; and 5,487,216.

The flat, tray-shaped suture package produced by the packaging machineset forth in the above-mentioned patents provides for the storagetherein of multiple surgical needles and attached sutures, whileconcurrently recognizing the need to facilitate the smooth andunobstructed withdrawal of individual needles and attached sutures fromthe suture package. For instance, such a suture package is disclosed inapplicants U.S. Pat. No. 5,230,424, which is commonly assigned to theassignee of the present application; and wherein the suture package isreferred to as an RSO package (Reduced Size Organizer).

In the specific design of the flat tray-shaped plastic container havinga peripheral channel as disclosed in the above-mentioned patent, thesuture package is basically constituted of a rectangular round-corneredand flat-bottomed injection-molded plastic tray having a flat centralsurface area including a raised needle clamping structure formed thereonfor engaging and "parking" a plurality of needles in a predeterminedspaced array. Sutures each have one end thereof attached to each of therespective needles so as to form so-called "armed sutures". The suturesextend from each of the needles into a channel extending about theperimeter or periphery of the suture tray and are conducted into thechannel so as to be essentially wound within the circumferentialconfines of the suture tray. The plurality of sutures which arepositioned within the suture tray channel are protected againstinadvertent outward displacement therefrom through the presence of amultiplicity of contiguously positioned resilient fingers which areintegrally molded with the suture tray, and which project outwardlyabove the confines of the channel along a major portion of the length ofthe channel and, collectively, form a so-called "zipper structure" inwhich the inherently resilient nature of the fingers facilitates theirtemporary raising up to enable the introduction of the sutures into thesuture tray channel by means of a suitable suture winding apparatus.

Although the rotary dial or turntable apparatus of the packaging machinepursuant to the foregoing U.S. patents provides for the packaging ofarmed sutures; in effect, needles with attached sutures, in a rapid andfully automated manner, such as by supplying the tray-shaped packages;thereafter parking the plurality of armed sutures in the packages,applying covers and removing the completed suture packages from themachine in a sequential station-to-station procedure, the machine wasdesigned to primarily produce suture packages each containing aplurality of armed sutures.

SUMMARY OF THE INVENTION

Pursuant to the present inventive concept, the above-mentioned automatedpackaging machine is further improved upon in a novel and unique mannerin that the machine is adapted to produce suture packages eachcontaining a single armed suture, such packages being frequently indemand rather than packages containing a plurality of needles andsutures. Thus, in order to provide for high production rates which areessentially compatible with those employed in the manufacture of suturepackages each containing a plurality of armed sutures, the presentinvention contemplates the provision of a fully automated packagingmachine with a considerably increased rate of operating speed andproduction capability so as to render the packaging machineseconomically viable in comparison with the previously describedautomated packaging machine, while maintaining structural and functionalreliability and ease of construction and maintenance.

In order to attain the essentially automated packaging ofsingly-packaged or individual surgical needles with attached sutures,the automated packaging machine pursuant to the invention sets forth theprovision of a rotary turret or dial-like turntable having a pluralityof tool nests each possessing a suture tray supporting surface, witheach tool next being circumferentially spaced about the turntable so asto be uniformly distributed about the periphery thereof. The rotaryturret is rotated to cause the tool nests supporting packaging trays tobe indexed forwardly so as to advance through a plurality of successiveworkstations which are adapted to, respectively, effectuate thesupplying of each of the trays located on the tool nests or supportsurfaces with a single or individual surgical needle and attachedsuture, winding the suture into the confines of each needle andsuture-containing tray, forming a latching engagement between a traycover and the tray; and thereafter conveying each completed suturepackage to a station for removal from the machine and transfer tostacking bins or the like.

Operatively communicating in synchronism with the indexing rotation ofthe rotary turret is a carousel device housing stacks of trays, which isadapted to supply empty trays sliced or separated from the bottom of arespective stack of the trays to a rotatable platform, and includesoperative robotic pivot arm structure to successively remove the traysfrom the rotatable platform and mount the empty trays on successive toolnests so as to be oriented in a vertical plane facing radially outwardlyof the rotary turret. Thereafter, each tray is indexed sequentiallyforwardly by the rotary turret to a workstation which will impartmovement to a portion of the tool nest having the tray supportedthereon, whereby the tray remains oriented essentially vertically it isrotated angularly relative to the horizontal plane of rotation of therotary turret. This movement enables a transfer device with a needle andsuture swaying mechanism processing needle grippers at a furtherworkstation to insert and position a surgical needle with its attachedsuture into a therewith aligned tray for retentive engagement withneedle-engaging structure formed in the tray so as to grip and park theneedle therein, with the suture extending from the needle and dependingdownwardly therefrom outwardly of the tray. The needle andsuture-containing tray is then advanced forwardly on its respective toolnest to successive workstations responsive to indexed advance of therotary turret wherein, at a first suture winding station, structureoperatively cooperating with the tray and the tool nest supporting thetray imparts an initial rotational movement to the tray about an axisperpendicular to the plane of the while maintaining tray the dependingsuture under tension, and at a second subsequent winding station impartsa rapid winding motion to the tray over multiple predetermined rotationsso as to fully wind the downwardly depending suture into a peripheraltray channel extending within the perimeter of the tray.

Thereafter, the tool nest mounting the tray with the needle parkedtherein and the attached suture which has been wound into the peripheralchannel of the tray is advanced to a further workstation responsive toindexed rotation of the rotary turret; at which workstation an operatingmechanism causes a bottommost cover to be sliced or separated from astack of covers and transferred to a rotatable platform. The cover isthen engaged by a robotically-controlled pivot arm which, under theaction of a vacuum, pivots the cover into a vertical orientation andapplies the cover onto the tray while concurrently imparting pressure tothe cover to cause cooperating latching structure to clampingly fastenthe cover to the needle and suture-containing tray. Upon completion ofthe cover-attaching sequence, the resulting completed suture package isindexed to a further workstation at which suitable grippers armmechanism engages the suture package, and the suture package isdisengaged from the tool nest on which it is supported and conveyedtransferred to and stacked in repository or receiving unit to be readiedfor further processing, such as sterilizing, over wrapping or the like,as may be required.

The foregoing sequence of operative steps is continually repeated foreach successive tool nest on the rotary turret or turntable sequentiallyreceiving empty trays from the carousel, while preceding tool nests eachmounting a tray are conveyed through the above-mentioned packagingcycle. Thus, a successive tray is always placed into a position ofreadiness at a following or subsequent workstation and processed in asimilar manner as before described during the forward indexing motion ofthe rotary turret or turntable. This ensures a continuously repetitivepackaging cycle for successive suture packages in a highly efficient andhigh-speed operation without the need for any manual intervention in theoperation of the packaging machine.

Intermediate various of the workstations as set forth hereinbefore;there may be arranged other workstations incorporating sensors adaptedto enable ascertaining the presence of empty trays at the initialworkstation, for a verification of a needle having been inserted intothe trays and for inspection of the trays subsequent to the winding ofthe sutures into the tray channels; checking for the application of thecovers to the trays, and facilitating the possible ejection ofincomplete trays or the removal from the machine of defective packages.

Accordingly, in order to facilitate the appropriate introduction of thesuture into the interior space of the package tray, subsequent to orconcurrently with the positioning the surgical needle and attached endof the suture in the tray and the transferring thereof, with a portionof the suture depending outwardly and downwardly therefrom, apparatus isprovided to capture the depending portion of the suture and to impartcontrollable tension thereto, until such time as the suture iscompletely wound into a suture-receiving channel formed in the tray.

Respecting the foregoing, pursuant to the invention, in order toeffectuate the capture and tensioning of the depending portion of thesuture which extends outwardly and downwardly of the tray mounting thesurgical needle to which the suture is attached, there is providedpreferably an air or vacuum-controlled clamping arrangement forcapturing the suture in which imparts a gripping action thereon. Uponthe package tray with the surgical needle contained therein beingadvanced to further workstations along the indexed advance of theturntable or tool nest-mounting dial, such as utilized for winding thesuture into the tray, the clamping arrangement releases the suture so asto enable the latter to be pulled upwardly towards the tray, but withtension and guidance being maintained on the suture by a plurality ofvacuum nozzles and through a further device imparting a vacuum conditionto the externally depending length of the suture. This will effectivelytension the suture and enable the latter to be wound into the tray atsubsequent suture winding workstations along the path of travel of theturntable.

It is, accordingly, an object of the present invention to provide anarrangement for capturing and controllably tensioning at least theportion of a suture extending from its attachment to the surgical needleand which depends outwardly and downwardly from the package traycontaining the parked surgical needle prior to the winding of the sutureinto the tray.

Another object of the present invention to provide a vacuum-controlledarrangement for capturing and maintaining tension on the portion of thesuture depending outwardly from the tray during advance of the packagetray from the needle feed and transfer workstation towards subsequentwinding workstations at which the suture is fully wound into theconfines of the tray.

Still another object of the present invention is to provide a method ofimplementing the capture and controllable tensioning of the portions ofa suture extending outwardly and downwardly from a package trayretaining a surgical needle and attached suture until the outwardlyextending suture portion has been fully wound into the tray.

A further object is to provide a method for capturing and tensioning theoutwardly projecting portion of a suture as described hereinabove byutilizing the inventive vacuum-generating suture capturing andtensioning arrangement.

BRIEF DESCRIPTION OF THE DRAWINGS

Reference may now be had to the following detailed description of apreferred embodiment of the automated packaging machine of theinvention, taken in conjunction with the accompanying drawings; inwhich:

FIG. 1 illustrates, generally diagrammatically, a plan view of themachine for the automated packaging of individual surgical needles andattached sutures, pursuant to the present invention;

FIG. 2 illustrates a side elevational view of the frame structure forthe machine of FIG. 1;

FIG. 3 illustrates a top plan view of the machine frame of FIG. 2;

FIGS. 4, 5 and 6 illustrate, respectively, side, top plan and front endviews of a tool nest utilized in the machine of FIG. 1;

FIG. 7 illustrates a bottom view of the dial or turntable mounting thetool nests, showing vacuum ports for communicating with the tool nestsand the vacuum clamp units for the sutures which extend outwardly of thepackage trays;

FIG. 8 illustrates a vacuum plenum for supplying the tool nests andvacuum clamp units with controlled vacuum conditions;

FIG. 9 illustrates a packaging tray having a surgical needle arrangedtherein upon the needle having been transferred thereto from a needletransfer mechanism;

FIG. 10 illustrates a plan view of the workstations of the packagingmachine at which the suture capturing and tensioning devices are inoperative conditions;

FIG. 11 illustrates an elevational view of the suture capturing andtensioning devices;

FIG. 12 illustrates a top plan view of suture winding arrangements;

FIG. 13 illustrates a front view of the suture winding head of FIG. 11with the suture clamp unit; and

FIG. 14 illustrates a side view thereof.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now in more specific detail to the drawings, FIGS. 1 to 3illustrate, in a generally diagrammatic plan view, the automated needleand suture packaging machine 10 pursuant to the invention. The machine10 comprises a rotary turret or turntable 12 which is essentially apackaging dial supported on an essentially stationary machine framestructure 14.

The rigid frame structure 14, as illustrated in FIGS. 2 through 4,basically includes structural uprights 16 and 18, which areinterconnected by horizontal beams 20, 22, 24, with the entire framestructure 14 adapted to be supported on a floor through the intermediaryof adjustable leveling footings 26. The frame structure 14 comprises anouter stationary frame arrangement 15, and an inner verticallyadjustable frame arrangement 17 comprising horizontal beams 28, 30 and32, and vertical beams 34, 36 interconnected therewith supporting theturntable 12 for vertical adjustment relative to the stationary machineframe components. The vertical adjustment of the frame arrangement 17 isprovided for by a central servo motor actuated jack screw 38, which alsoconcurrently effectuates the vertical adjustment of all of the operativepackaging devices at the various workstations of the machine so as toaccommodate the packaging of a wide range of differently sized surgicalneedles without the necessity for modifying any machine components.Arranged within the frame structure are the various belt drives 40, 42,44, 46 and 48 and operating drive components 50 for the machine, and thevacuum-generating systems 52 employed in the packaging cycles for thesuture packages, as described hereinbelow. The turntable 12 is orientedin a horizontal plane, and through the intermediary of aprogram-controlled drive installation, is rotatable in an indexing orincrementally angular advance about a central vertical axis 54. In thisinstance, during operation of the machine, the turntable 12 is rotatedin a counter-clockwise direction when viewed from above, as representedby arrow A, so as to be advanced in 30° increments.

The rotary turret or turntable 12 is essentially constituted of acircular disk-shaped member or packaging dial which has a plurality oftool nests 60 mounted thereon. The tool nests 60 are mounted in acircumferentially uniformly spaced array on the upper surface of thepackage dial or rotary turret 12, and with each tool nest 60 having anouter end projecting radially outwardly of the peripheral edge of theturret or dial 12, as described hereinbelow.

In this particular construction of the packaging machine 10, by way ofexample, twelve (12) tool nests 60 are arranged at uniformly distributedannular spacings of 30° from each other about the circumference of thedial or rotary turret 12.

In essence, as mentioned hereinbelow, the rotary turret or turntable 12of the packaging machine 10 is adapted to be indexed forwardly in anangularly incremental or indexed rotational advance, each suchincremental advance comprising one-twelfth of the 360° circumferentialrotation of the turntable, or basically 30°, along the direction ofrotation identified by arrow A in FIG. 1, such that the tool nests 60which are each adapted to mount a suture tray or package are designed tobe advanced in sequence to a number of successive workstations;designated herein as workstations (1) through (12), which arestationarily evenly spaced about the periphery of the rotary turret 12,as illustrated in FIG. 1 of the drawings.

The successive workstations which collectively constitute the automatedmachine 10 for the packaging of surgical needles and attached suturesare essentially briefly described as follows; viewed in the direction ofrotation of arrow A:

(1) A first workstation 70 relates to the operative aspect of emptysuture package trays being successively separated from the bottom ofstacks of trays contained in a rotary carousel 72 to be transferred ontoa rotationally indexed plate 74 under the action of a vacuum, andthereafter picked up and transferred by a cam-controlled robotic pivotarm structure 76 to successive tool nests 60 so as to be retainedthereon while being conveyed by the rotary turret or dial 12 tosubsequent workstations, as set forth hereinbelow.

(2) At this workstation 80, to which the respective tool nest 60supporting the empty tray thereon has been advanced by the rotationaladvance of the turntable 12 mounting the tool nest; in effect, indexed30° forwardly; operative slide-controlled pivot structure 82 engages aplate element on the outer end of the tool nest 60 which supports theempty tray under a vacuum, and rotates the plate element and traycounterclockwise within the vertical plane thereof about a horizontalradial axis of the tool nest 60 through an angle of approximatelysixteen and one-half (16.5°) degrees so as to be in appropriate angularorientation relative to a horizontal axis for facilitating thesubsequent insertion and retention of a surgical needle and attachedsuture into the tray.

(3) This workstation 84 provides for a sensor 86 which is mountedstationarily on a bracket arrangement 88 and faces the tool nest 60 soas to be able to check for the presence of an empty tray on the toolnest. The sensor 86 is suitably aimed at a black spot present on thepackaging tooling nest, and in the absence of a tray being positionedthereon, enables deactivating the forward advance of the turntable 12and concurrently may emit a signal to alert personnel regarding themissing tray.

(4) The next workstation 90 along the rotational path of motion of theturntable in the direction of arrow A, provides gripper mechanism 92 forinserting a single surgical needle and a therewith attached suture intothe suture tray which has been indexed forwardly by the rotary turret 12so as to be located in operative alignment with the needle-feedmechanism. The needles are conveyed by a mechanism so as to be mountedon suitable clamping or needle "park" structure constituting an integralportion of the tray. Vacuum-controlled suture capture and tensioningdevices which are located below each tool nest 60, become operative atthis workstation to capture and tension the suture portions dependingoutwardly and downwardly of the tray mounting the surgical needle.

(5) At this workstation 94, a stationary sensor 95 located radiallyoutwardly of the turntable 12 may be utilized to ascertain the presenceof a surgical needle and attached suture having been properly introducedinto the tray at the previous workstation 90.

(6) A first tray winding mechanism 96 at this workstation 98 engages theplate element on the tool nest supporting the tray, while the suturecapture and tensioning device ensures that the suture portion dependingoutwardly and downwardly from the tray is maintained under tension by avacuum-operated tensioning device associated therewith, with the traybeing rotated counterclockwise within its vertical plane throughapproximately 163.5°, to assume a horizontal orientation which is 180°inverse to its original orientation on the tool nest 60 at workstation(1), and with the remaining length of the suture being tensioned by thevacuum device externally of the tray.

(7) At a subsequent workstation 100, a further winding mechanism 102engages the tool nest 60 and the tray mounted thereon, and imparts rapidrotation to the tray so as to enable tray structure engaging portions ofthe mechanism to introduce and completely wind the entire remaininglength of the suture into a peripheral groove extending about theconfines of the tray.

(8) A stationary sensor 104 at this workstation 106 is located radiallyoutwardly of the turntable 12, and is adapted to ascertain thepositioning of the surgical needle in the tray.

(9) This workstation 110 provides apparatus for the application andattachment of a cover or label to the tray containing the surgicalneedle and attached suture to produce or complete suture to produce acomplete suture package. A rotatably indexed disc-like plate 112includes a plurality of equidistantly circumferentially spacedcover-receiving areas, these being rotated below a vertical stack 114 ofcovers or labels such that, under the action of a vacuum, the bottommostcovers of the stack are sequentially sliced off or separated anddeposited into a respective area of the plate under the influence of thevacuum present therebeneath, and thereafter rotated into radialalignment with a tool nest 60 mounting the tray containing the surgicalneedle and attached wound suture. A cam-controlled robotic pivot armstructure 116 lifts the cover from the plate, while a subsequent areareceives a further cover from the stack for transfer onto a followingtray, and pivots upwardly and extends horizontally forwardly so as toposition the cover into latching engagement with the tray, therebyforming the completed suture package.

(10) A robotic pivotable gripper arm 120 removes the completed packagefrom the tool nest 60 at this subsequent workstation 122, and swingsdownwardly so as to deposit the completed suture package into receivingbins or compartments within elongated tray members 124 whereby upon acertain amount of trays being deposited to fill the tray member thelatter is indexed to align a further empty compartment of a tray memberwith the tool nests. The tray member having the various filledcompartments is then conveyed to a storage unit 126 and replacedautomatically by another empty tray member.

(11) In the event of a suture package being defective, such as having acover lacking or misplaced, and the resultant package has accordinglynot been removed at the preceding package unloading workstation 122; atthis workstation 130 a reciprocating arm structure 132 has a gripperhead which engages and removes the rejected packages from the toolnests, and deposits them onto a conveyor belt 134 for conveyance to asuitable waste disposal site.

(12) A sensor 77 at the final workstation on the packaging machine 10checks for the presence of a package that may not have been removed atstations (10) and (11). This is a further safegard built into thepackaging machine to ensure that the tool nest at station (1) is emptyand ready to accept an empty package tray.

As shown in FIGS. 4 through 6, each tool nest 60 includes a housing 140which is fixedly mounted on the upper surface 142 of the rotary turret12. Each housing 142 includes a horizontal radially extending centralthrough bore having a shaft 144 rotatably journaled therein. The shaft144 is normally secured against rotation within housing 140; however, atpredetermined workstations of the machine, the shaft 144 may be releasedby means of a locating pin 141 so as to be axially radially inwardlymovable within housing 140 against stationary cam structure 143 mountedcentrally on the rotary turret or dial 12 for regulating the rotationaldisplacement which may be imparted to the shaft 144, as discussedhereinbelow in more specific detail.

The radially outwardly facing structure 148 of a plate element 150,which is fixedly secured to the radially outer end of shaft 144, isadapted for supporting suture package components, and particularly thepackage trays which are utilized in the production of surgical needleand attached suture-containing packages.

In essence, the radially outer structure of the tool nest housing 140for mounting suture trays includes the plate element 150 which comprisesan elongate vertically oriented plate member 152 having generallyparallel opposite sides 154 and convexly rounded opposite ends 156 so asto be generally in conformance with the peripheral shape of a packagetray. An external planar surface on the plate member 152 includesprotruding perimeter or rim structure 158 for seating engagement thereinof a suture tray, with the plate member 152 being fixedly secured to theradially outer end of the shaft 144 so as to be adapted for rotationtherewith. Extending forwardly from the external planar surface of therotatable plate member 152 of the tool nest 60 are protuberances orguide pins 160 which are intended to align the package tray thereon forappropriate positioning on the plate member 152, with the tray adaptedto be retained thereon through the application of a vacuum to theexterior plate member surface through passageways communicating with avacuum source connected thereto through the tool nest housing 140.

The vacuum passageways extend through the lower surface 162 of the dialor turntable 12, as shown in FIG. 7, which includes a plurality ofapertures 164 each communicating with, respectively, passageways leadingto an associated tool nest 60. The vacuum is supplied to the apertures164 in a selective controlled mode through the intermediary of astationary vacuum plenum 166 arranged below the dial 12, as shown inFIG. 2 of the drawings. The plenum 166, as shown in FIG. 8, includesoutlet slots 168 and ports 169 for applying or closing a vacuum torespective tool nests 60 in accordance with the rotational positions ofthe dial 12 with the aperture or ports 164 in the lower surface 162being in communication with the vacuum plenum outlet slots or ports.

With respect to the features of the packaging machine 10 which aredirected to a provision of arrangements for capturing and tensioning theportion of the suture which depend outwardly of a packaging tray 170during the cycle portion of machine operation in which the surgicalneedle and attached suture is transferred into and parked in a tray atneedle feed or transfer workstation 90 (4) and until completion of thewinding of the entire length of suture into the confines of thepackaging tray, appropriate controlled tension must be maintained on theoutwardly depending suture portion in order to avoid any snaggingthereof which would inhibit or adversely affect the unobstructed windingof the suture into a channel formed in the tray 170.

The suture package tray 170, as shown in FIG. 9 of the drawings, isessentially constituted of molded plastic material, and includes aplanar base 172 with parallel sides and semi-circular rounded ends. Avertical wall 174 extends about the perimeter of the tray, whileinwardly spaced thereof is a second vertical wall 176 having radiallyoutwardly extending fingers 178 which are flexible at the upper edgereaching close to the outer wall 174 so as to define a hollow channelstructure. Apertures and surgical needle engaging structure is moldedinto the tray, as more specifically disclosed in copending U.S. Pat.application Ser. No. 08/521,978; filed Aug. 31, 1995 now U.S. Pat. No.5,660,024, the disclosure of which is incorporated herein by reference,and which is commonly assigned to the assignee of this application.

As shown in FIG. 9 of the drawings, the packaging tray 170 is pivotedcounterclockwise on the tool nest 60 to be at an angle of 16.5° relativeto the horizontal, and remains at that angular orientation until theoutwardly depending suture portion is begun to be wound into thepackaging tray 170.

Illustrated diagrammatically in FIG. 10 is a view of the workstations(4) through (7), between which there is effected the capture andtensioning of the suture portions extending outwardly from the packagingtray. At workstation (4), the surgical needle with attached suture hasbeen transferred into the packaging tray 170 by the needle transferapparatus disclosed in copending application Ser. No. 09/020,091(Attorney Docket ETH-1191; 10196), the disclosure of which isincorporated herein by reference.

As the turntable 12 and the packaging trays 170 on the tool nest platemembers 150 are advanced in the direction of arrow A, so that the tray170 is indexed past the sensor workstation (5) at which it is inspectedfor the presence of a needle, and then indexed forwardly to windingstations (6) and (7), the suture capturing and tensioning system 190 isactivated.

At the first winding workstation (6) a slide element 194 is reciprocatedso that a winding head 196 causes a pin to engage the plate member 150on tool nest 60. A drive (not shown) then rotates the plate member 150together with the packaging tray 170 thereon counterclockwise through163.5° so as to assume a horizontal orientation for the longitudinaltray axis. Thereafter, at the second winding workstation (7), a windinghead 200 mounted on a rotatable winding unit 202 which is driven by amotor 204, causes the suture to be fully wound into the packaging tray170. The winding stations (6) and (7) and the operative structures anddetailed functions thereof are described in detail in copendingapplication Ser. No. 09/020,191 (Attorney Docket ETH-1193; 10198), thedisclosure of which is incorporated herein by reference.

Referring in particular to FIGS. 11 to 14 of the drawings, there isillustrated a vacuum-operated suture clamping unit 210, of which oneeach is mounted on the lower surface of turntable 12 beneath eachrespective tool nest 60 so as to extend below the plane of turntable 12.Each vacuum-operated suture clamping unit 210 is operative connectedthrough the vacuum plenum 166 with a vacuum-generating system 212provided in the packaging machine 10 and may be supplied with acontrolled vacuum through suitable vacuum ports 214 and passageways asshown in FIG. 14 of the drawings, when a vacuum is intended to besupplied to sutures captured therein during predetermined operatingintervals. In this instance, the clamping unit 210, which includes aplurality of vacuum nozzles or fingers 216 as illustrated in FIGS. 13and 14, is rendered operative when a surgical needle is inserted intothe packaging tray 170 at workstation (4), in effect, at the needle feedor transfer work station. The suture portion which extends outwardly anddownwardly of the tray 170 from its end which is attached to thesurgical needle which is is parked in the tray, is captured by thevacuum-operated clamping unit 210 through the intermediary of vacuumnozzles 216 at a location which is below the therewith associated toolnest 60.

When the surgical needle has been inserted into the tray 170 and thesuture portion depends outwardly and downwardly therefrom, asillustrated in FIG. 11 of the drawings, it extends through the clampingunit 210, as shown in FIG. 11, and extends downwardly through a furthervacuum nozzle arrangement 220 for tensioning the suture portion, andinto a further lower suture tensioning device (not shown) which is alsovacuum-operated and tensions the trailing end of the suture portion.Upon the tool nest 60 and the tray 170 with the surgical needle andattached suture having been advanced to the winding station (6) forinitially rotating the tray 170 at winding station (6), shown in FIG.13, and then advanced towards winding station (7) for winding the entiresuture length into the confines of the tray 170, the vacuum in thenozzles 216 of clamping unit 210 is released, thereby permitting upwardsliding movement therethrough of the outwardly extending suture portiontowards the tray 170.

Moreover, as shown in FIGS. 11 and 12, a guide arrangement 230 for thedepending suture portion is provided at winding workstation (7) belowthe clamping unit 210. The guide arrangement may comprises a pair ofplates 232, 234 having wing portions 236 forming a conveying passageway238 through which the suture is guided towards the winding head.

However, the suture is maintained under tension in that the vacuum isapplied by the plurality of vacuum nozzles or fingers 240 which arelocated below the vacuum clamping unit 210. Consequently, althoughtension is maintained on the suture through the application of a vacuum,the suture is still permitted to move relative to the workstation at thesurgical needle has been inserted into the tray, and at the workstationswherein the suture is adapted to be wound into the tray, as illustratedin copending application Ser. No. 09/020,191 (Attorney's DocketETH-1193; 10198), the disclosure of which is incorporated herein byreference.

From the foregoing, it becomes readily apparent that the utilization ofthe vacuum-operated units 210 for capturing and the vacuum nozzle orfinger devices for tensioning the suture portion which depends outwardlyof the tray 170 when the latter has the surgical needle and attachedsuture end portion positioned therein, clearly facilitate the winding ofthe suture at subsequent workstations into the package tray whilemaintaining vacuum-generated control and tension on the suture, thusavoiding any snagging of the suture while being advanced and then woundinto the tray.

While there has been shown and described what are considered to bepreferred embodiments of the invention, it will, of course, beunderstood that various modifications and changes in form or detailcould readily be made without departing from the spirit of theinvention. It is, therefore, intended that the invention be not limitedto the exact form and detail herein shown and described, nor to anythingless than the whole of the invention herein disclosed as hereinafterclaimed.

What is claimed is:
 1. A suture capture and tensioning arrangement in amachine for the automated packaging of a single needle having anattached suture to produce a suture package, wherein said machineautomatically winds said suture within confines of a tray and attaches acover to said tray so as to constitute said suture package, said machinehaving at least one tool nest for supporting said tray, and means forimparting a forwarding motion to said tool nest and said tray supportedthereon for indexed advance to a plurality of workstations stationarilyarranged proximate a path of advancing movement of said at least onetool nest; said arrangement comprising:(a) suture clamping means locatedproximate said at least one tool nest, said suture clamping means beingactivated to clampingly engage a portion of a suture attached to asurgical needle retained in a tray mounted on said tool nest anddepending therefrom at a workstation for feeding said needle to saidtray; (b) first vacuum-generating means for imparting a tension to saiddepending suture portion; (c) and second vacuum-generating means forimparting tension to a trailing end of said depending suture portion. 2.An arrangement as claimed in claim 1, wherein said clamping means isactivated at a workstation of said machine at which said surgical needleis transferred into said tray on a support surface of said tool nest soas to clampingly engage said depending suture portion, and isdeactivated to release said suture portion upon said tool nest havingadvanced towards a subsequent winding workstation.
 3. An arrangement asclaimed in claim 1, wherein said first and second vacuum-generatingmeans maintain tension on said depending suture portion during advanceof said tool nest mounting said needle-containing tray towards asubsequent workstation.
 4. An arrangement as claimed in claim 3, whereinsaid subsequent workstation comprises at least one further workstationfor winding said depending suture portion into the confines of saidtray.
 5. An arrangement as claimed in claim 4, wherein said secondvacuum-generating means continually imparts tension to the trailing endof said depending suture portion until the latter is wound into saidtray.
 6. An arrangement as claimed in claim 3, wherein said first andsecond vacuum-generating means are positioned proximate needle feedingand suture winding workstations of said machine.
 7. An arrangement asclaimed in claim 1, wherein said suture clamping means is fixedlyconnected with said at least one tool nest so as to be forwardly movablein conjunction therewith.
 8. An arrangement as claimed in claim 1,wherein said clamping means is activated by a vacuum.
 9. An arrangementas claimed in claim 1, wherein a plurality of said tool nests aremounted peripherally spaced about a rotatably indexed turntable, eachsaid tool nest having respectively one said clamping means fixedlyconnected therewith.
 10. An arrangement as claimed in claim 9, whereineach said clamping means is fastened to said turntable beneath atherewith associated tool nest.
 11. A method of capturing and tensioningsutures in a machine for the automated packaging of a single needlehaving an attached suture to produce a suture package, wherein saidmachine automatically winds said suture within confines of a tray andattaches a cover to said tray so as to constitute said suture package,said machine having at least one tool nest for supporting said tray, andimparting a forwarding motion to said tool nest and said tray supportedthereon for indexed advance to a plurality of workstations stationarilyarranged proximate a path of advancing movement of said at least onetool nest; said method comprising:(a) effecting suture clampingproximate said at least one tool nest, said suture clamping beingactivated to engage a portion of a suture attached to a surgical needleretained in a tray mounted on said tool nest and depending therefrom ata workstation for feeding said needle to said tray; (b) through a firstvacuum-generating device imparting a tension to said depending sutureportion; (c) and through a second vacuum-generating device impartingtension to a trailing end of said depending suture portion.
 12. A methodas claimed in claim 11, wherein said clamping is activated at aworkstation of said machine at which said surgical needle is transferredinto said tray on a support surface of said tool nest so as toclampingly engage said depending suture portion, and is deactivated torelease said suture portion upon said tool nest having advanced towardsa subsequent winding workstation.
 13. A method as claimed in claim 11,wherein said first and second vacuum-generating devices maintain tensionon said depending suture portion during advance of said tool nestmounting said needle-containing tray towards a subsequent workstation.14. A method as claimed in claim 13, wherein said subsequent workstationcomprises at least one further workstation for winding said dependingsuture portion into the confines of said tray.
 15. A method as claimedin claim 14, wherein said second vacuum-generating device continuallyimparts tension to the trailing end of said depending suture portionuntil the latter is wound into said tray.
 16. A method as claimed inclaim 13, wherein said first and second vacuum-generating devices imparttension proximate needle feeding and suture winding workstations of saidmachine.
 17. A method as claimed in claim 11, wherein said sutureclamping is effected by means fixedly connected with said at least onetool nest so as to be forwardly movable in conjunction therewith.
 18. Amethod as claimed in claim 11, wherein said clamping is activated by avacuum.
 19. A method as claimed in claim 11, wherein a plurality of saidtool nests are mounted peripherally spaced about a rotatably indexedturntable.